Low-Cost and Scalable Platform with Multiplexed Microwell Array Biochip for Rapid Diagnosis of COVID-19

Yang Wang; Kaiju Li; Gaolian Xu; Chuan Chen; Guiqin Song; Zaizai Dong; Long Lin; Yu Wang; Zhiyong Xu; Mingxia Yu; Xinge Yu; Binwu Ying; Yubo Fan; Lingqian Chang; Jia Geng

doi:10.34133/2021/2813643

Low-Cost and Scalable Platform with Multiplexed Microwell Array Biochip for Rapid Diagnosis of COVID-19

Research (Wash D C). 2021 Mar 12:2021:2813643. doi: 10.34133/2021/2813643. eCollection 2021.

Authors

Yang Wang¹, Kaiju Li², Gaolian Xu³, Chuan Chen², Guiqin Song², Zaizai Dong¹, Long Lin¹, Yu Wang², Zhiyong Xu⁴, Mingxia Yu⁵, Xinge Yu⁶, Binwu Ying², Yubo Fan¹, Lingqian Chang¹, Jia Geng²

Affiliations

¹ Beijing Advanced Innovation Center for Biomedical Engineering, Key Laboratory for Biomechanics and Mechanobiology, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China.
² Department of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation Center, Chengdu 610041, China.
³ Nano Biomedical Research Centre, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai 200030, China.
⁴ Wuhan Chain Medical Labs, Wuhan, Hubei 430011, China.
⁵ Department of Clinical Laboratory, Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China.
⁶ Department of Biomedical Engineering, City University of Hong Kong, China.

Abstract

Sensitive detection of SARS-CoV-2 is of great importance for inhibiting the current pandemic of COVID-19. Here, we report a simple yet efficient platform integrating a portable and low-cost custom-made detector and a novel microwell array biochip for rapid and accurate detection of SARS-CoV-2. The instrument exhibits expedited amplification speed that enables colorimetric read-out within 25 minutes. A polymeric chip with a laser-engraved microwell array was developed to process the reaction between the primers and the respiratory swab RNA extracts, based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP). To achieve clinically acceptable performance, we synthesized a group of six primers to identify the conserved regions of the ORF1ab gene of SARS-CoV-2. Clinical trials were conducted with 87 PCR-positive and 43 PCR-negative patient samples. The platform demonstrated both high sensitivity (95.40%) and high specificity (95.35%), showing potentials for rapid and user-friendly diagnosis of COVID-19 among many other infectious pathogens.